MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US LCS COM POST AUG 5MM LG+; LCS COMPLETE : KNEE FEMORAL ACCESSORY

Catalog Number	129427070
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Revision total knee replacement (b)(6) private hospital (b)(6) 2018.Patient underwent primary total knee replacement in 2015 (dr (b)(6)), where an lcs tkr was utilised (cat number and date/ place to follow when available).The 1st revision, patient had stiffness and pain, patient underwent a revision tkr in 2016 (dr (b)(6)), and then 2nd revision additional surgery in 2017 where the patella component was revised (dr (b)(6)).Patient has now presented with stiffness, pain and instability.Patient struggles on stair accent and decent.Night pains, especially severe when rolling over.A decision was made to revise the knee (dr (b)(6), (b)(6) hospital 5/03/18) on opening the knee the knee was tight in flexion and loose from 10 degrees flexion to approximately 45 degrees of flexion, with knee gapping up to 7-10mm.The knee was revised to a tc 3 rp.Male patient (b)(6).Unknown_jrn: lcs large fem, unknown_jrn: size 5 mtb tray, unknown_jrn: 2 x universal stems, unknown_jrn: lcs bearing large 10mm.
Additional Manufacturer Narrative
(b)(4).Investigation summary no information received with this individual complaint indicated that a broader investigation or corrective action was necessary.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LCS COM POST AUG 5MM LG+
• Common Device Name: LCS COMPLETE : KNEE FEMORAL ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7376797
• Report Number: 1818910-2018-56233
• Device Sequence Number: 1482089
• Product Code: NJL
• UDI-Device Identifier: 10603295025405
• UDI-Public: 10603295025405
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 129427070
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR